Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 9, 13 and 16 are canceled. Claims 1-8, 10-12, 14-15 and 17-18 are pending and under consideration.
In light of the amendment filed on 12/10/2025, Rotovap in paragraphs [0039] and [0087] was replaced with “a rotovap”, which is understood to be the generic terminology for any rotary evaporator. The objection to the specification for the use of a trademark is withdrawn.
The instant claims are entitled to an effective filing date of 03/30/2022.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendment filed on 12/10/2025 has introduced new matter into the claims.
Claim 7 as amended on 12/10/2025 recites the method of claim 1, wherein the step (a) is carried out at a temperature from 60˚C - 100˚C under vacuum and at atmospheric pressure.
Applicant's amendment, filed 12/10/2025, asserts that no new matter has been added. See the first paragraph on page 8 of the remarks. However, the specification and the original claims do not provide sufficient written description of the above underlined limitations.
Claim 7 contains new matter because of the limitation requiring step (a) to be carried out both under vacuum pressure and at atmospheric pressure. A vacuum is a volume that contains little or no matter and has a low pressure. See the first paragraph on page 1 of evidentiary reference Helmenstine (2022; reference U on page 1 of the PTO-892 form).
The specification as filed and the original claims do not provide support for this limitation in claim 7. The specification teaches a method wherein step (a) is carried out at a temperature of from about 60° C - 100° C under vacuum or at atmospheric pressure. See [0026], [0054]-[0056]. In some embodiments, the heating is done in a vacuum, at atmospheric pressure or under controlled pressure. See [0071]. The specification teaches using a high vacuum distillation column. At the start of the distillation, approximately 1 liter of filtered GBL liquid is charged into the bottom of the column, the condenser cooling water and the vacuum are then turned on. Once the pressure is stabilized, the filtered GBL liquid is slowly heated using a heating mantle to the boiling point of GBL (204° C.). See [0105]. However, the specification is silent regarding introducing a starting biomass to an evaporator under a vacuum and at atmospheric pressure.
Such limitations recited in the instant claim 7, which did not appear in the specification or original claims, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C 112. Applicant is required to provide sufficient written support for the limitations recited in the instant claim. Applicant can remove the new matter limitations from the claims to obviate this rejection.
Scope of Enablement
Claims 1-8, 10-12, 14-15 and 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of producing gamma-butyrolactone (GBL) product from a starting biomass containing water and genetically engineered E. coli cells designed to yield poly-4-hydroxybutyrate (P4HB) from glucose syrup as a carbon feed source, the method comprising: (a) introducing the starting biomass to an evaporator, (b) introducing liquid or vapor GBL to the evaporator as a solvent in a weight equivalent to or less than a weight of water removed to obtain a biomass suspension or solution that contains 5 wt% or less of water based on the weight of the biomass suspension or solution and comprises P4HB dissolved or suspended in the GBL, (c) combining the biomass suspension or solution that contains 5 wt% or less of water based on the weight of the biomass suspension or solution and a sodium carbonate or calcium hydroxide conversion catalyst and heating the resulting mixture to convert the P4HB to GBL, and (d) collecting the GBL, wherein the liquid or vapor GBL introduced in step (b) is a recycle GBL that is a part of the collected GBL obtained in step (d) and recycled back to the evaporator to be mixed as a solvent with the biomass, wherein the method does not include a drying comprising spray drying or drum drying.
The specification does not reasonably provide enablement for a method of producing GBL product from a starting biomass containing water and P4HB-containing cells, the method comprising: (a) introducing the starting biomass to an evaporator, (b) introducing liquid or vapor GBL to the evaporator as a solvent in a weight equivalent to or less than a weight of water removed to obtain a biomass suspension or solution that contains 5 wt% or less of water based on the weight of the biomass suspension or solution and comprises P4HB dissolved or suspended in the GBL, (c) combining the biomass suspension or solution that contains 5 wt% based on the weight of the biomass suspension or solution and a conversion catalyst and heating resulting mixture to convert the P4HB to GBL, and (d) collecting the GBL, wherein the liquid or vapor GBL introduced in step (b) is a recycle GBL that is a part of the collected GBL obtained in step (d) and recycled back to the evaporator to be mixed as a solvent with the biomass, and wherein the method does not include a drying comprising spray drying or drum drying, and wherein the starting biomass is a genetically engineered biomass from a host cell that includes a non-naturally occurring amount of P4HB. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims and the nature of the invention:
Under the broadest reasonable interpretation, the claims are drawn to a method of producing GBL from a starting biomass containing water and any cell containing P4HB, the method comprising: (a) introducing the starting biomass to an evaporator, (b) introducing recycled liquid or vapor GBL to the evaporator in a weight equivalent to or less than a weight of water removed in order to obtain a biomass suspension or solution that comprises P4HB in GBL, (c) combining that biomass suspension or solution with any compound that can serve as a catalyst in the presence of heat to convert P4HB to GBL, and (d) collecting the GBL, and wherein the method does not include a drying comprising spray drying or drum drying.
The claims require the starting biomass to be a genetically engineered biomass from a host cell that includes a non-naturally occurring amount of P4HB. Yet, the genetic modification is not limited in anyway. As such, the starting biomass encompasses a breadth of genetic mutations.
The claims encompass any compound capable of catalyzing the conversion of P4HB to GBL. The specification discloses that the term “gamma-butyrolactone product” or “GBL” refers to a product that contains at least about 80 up to 100 weight percent gamma-butyrolactone. See [0084]. Thus, the claims encompass any compound capable of catalyzing the conversion of P4HB to a product that contains at least about 80 up to 100 weight percent GBL in the presence of any heated temperature.
The state of the prior art and the level of predictability in the art:
With respect to the state of the art on P4HB-containing cells, Mitra (Molecules, 2021, 26(23), 7244) suggests that researchers are continuously engrossed in developing various strategies to realize P4HB synthesis in microbes. See the first paragraph on page 2. Mitra discloses that E. coli can produce P4HB using glucose if it is genetically modified to express a phaCAB gene cluster and phaP1 gene from C. necator, and orfZ-sucD-4hbD from C. kluyveri; and genetically modified to knock out the sad and gabD genes. Moreover, E. coli can produce P4HB using xylose and 4-hydroxybutyric acid as substrates, or using glycerol and propionic acid as substrates if it is genetically modified to express phaC from C. necator and orfZ from C. kluyveri. See table 1. Mitra concludes that P4HB is a promising biomaterial in the biomedical field, however its synthesis is a constraint as most microbes lack 4HB synthesis pathways. See section 5. For GBL production, Peoples (US 2016/0068463), in example1, teaches producing a biomass containing P4HB using a genetically modified E. coli strain specifically designed for high yield production of P4HB from glucose syrup as the sole carbon feed source. The use of a renewable resource-based feedstock such as glucose syrup as the sole carbon source enables the production of a biobased P4HB and hence the production of biobased GBL and derivatives. The E. coli strain generates a fermentation broth that has a P4HB titer of approximately 100-120 g of P4HB/kg broth. After fermentation, the broth is washed and mixed with standard hydrated lime Ca(OH)--2. See [0175]. During pyrolysis the products of the thermal degradation of biomass+P4HB, GBL, is collected in a condensate trap. See [0178]. The GBL product yield (g of GBL product/ g of starting P4HB)x100) is approximately 87%. See [00179]. Thus, Mitra illustrates the breadth of P4HB containing cells and Peoples teaches producing biobased GBL with a specific P4HB containing cell.
With respect to the state of the art on catalysts for the P4HB to GBL conversion, Walsem (US 2014/0110482) teaches the effect of the temperature, catalyst type, catalyst concentration and broth type on the purity of GBL from the pyrolysis of a genetically engineered microbe producing P4HB. In example 10, Walsem teaches 16 different experimental conditions. See [0138]. Biomass containing P4HB is produced using genetically modified E. coli strain specifically designed for high yield of production P4HB from glucose syrup. See [0139]. For pyrolysis the catalysts include Ca(OH)2 [calcium hydroxide], Mg(OH)2, FeSO4 7H2O, and NaCO3 [sodium carbonate]. See [0140]. Walsem suggests that catalyst type is the most significant variable affecting the degradation rates which varied from -1 to -185% wt. Samples with the highest degradation rates are those with either Na2CO-3 or Ca(OH)2. See [0144]. Whereas samples with FeSO4 catalyst have lower degradation rates. See [0144]. Thus, Walsem illustrates the unpredictability of using any catalyst type.
The amount of direction provided by the inventor and the existence of working examples:
The instant specification provides one working example of a biomass containing P4HB. In example 1, a biomass containing P4HB is produced using a genetically modified E. coli strain specifically designed for high yield production of poly-4HB from glucose syrup as a carbon feed source. Examples of the E. coli strains, fermentation conditions, media and feed conditions are described in, for example, US 6,316,262 (as cited in the IDS filed 03/28/2023). After fermentation, a broth containing about 10% by weight of P4HB, 10% by weight of biomass and salts is obtained. See [0092]. In example 2, the washed broth is fed to a first evaporator, transferred to a second evaporator where a recycled stream of GBL is fed to replace the water removed in the first evaporator and heated to remove about 40% more water. The resulting solution is transferred to a third evaporator to remove the remaining water. The resulting slurry contains about 25% by weight P4HB and about 47% by weight of GBL. See [0094]. To increase the purity of the GBL, the slurry is subjected to filtration, which produces a polymer solution containing about 30% P4HB and about 66% GBL. See [0095]. The filtered substantially water-free biomass solution is mixed with standard hydrated lime Ca(OH)2 [calcium hydroxide]. Pyrolysis of the GBL+P4HB+ Ca(OH)2 is carried out and condensate is collected. See [0096]. After pyrolysis, the results show that the condensate contains 3% water, 0.06% fatty acids with the balance of material being GBL products. The GBL yield (g of GBL product/g of starting P4HB)x100%) is approximately 87% and the purity of the GBL is about 99%. See [0098]. Thus, the specification provides one working example of a genetically modified E. coli biomass capable of producing P4HB for the production of GBL.
The quantity of experimentation needed to make or use the invention:
In view of the nature of the invention, the breadth of the claims, the guidance and
working examples in the specification, and the level of predictability within the art, as
evidenced above, one skilled in the art could not produce biobased GBL using any and all types of P4HB-containing cells, any and all types of conversion catalysts and without any form of a drying step. Prior to the effective filing date of the instantly claimed invention, it was well known that biobased gamma-butyrolactone can be produced using a genetically engineered E. coli designed to yield P4HB from glucose, and using calcium hydroxide or sodium carbonate catalysts, as evidenced by Walsem. However, Mitra suggests that researchers continue to develop strategies to realize P4HB synthesis in microbes; and Walsem suggests different catalysts have different effects on GBL products. Thus, biobased GBL production would be unpredictable in a process that encompasses any P4HB-containg cell, any conversion catalyst and no drying steps.
Accordingly claims 1-8, 10-12, 14-15 and 17-18 are enabled for a method of producing gamma-butyrolactone (GBL) product from a starting biomass containing water and genetically engineered E. coli cells designed to yield poly-4HB from glucose syrup as a carbon feed source, the method comprising: (a) introducing the starting biomass to an evaporator, (b) introducing liquid or vapor GBL to the evaporator as a solvent in a weight equivalent to or less than a weight of water removed to obtain a biomass suspension or solution that contains 5 wt% or less of water based on the weight of the biomass suspension or solution and comprises P4HB dissolved or suspended in the GBL, (c) combining the biomass suspension or solution that contains 5 wt% or less of water based on the weight of the biomass suspension or solution and a sodium carbonate or calcium hydroxide conversion catalyst and heating the resulting mixture to convert the P4HB to GBL, and (d) collecting the GBL, wherein the liquid or vapor GBL introduced in step (b) is a recycle GBL that is a part of the collected GBL obtained in step (d) and recycled back to the evaporator to be mixed as a solvent with the biomass.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
§112(a) rejection of claims 1-8, 10-12, 14-15 and 17-18
Applicant argues that claim 1 was amended to recite that the starting biomass is genetically engineered biomass from a host cell that includes a non-naturally occurring amount of P4HB, thereby further specifying the biomass used to obtain a high-concentration GBL product. See the last full paragraph on page 10 of the remarks.
This argument is not persuasive because the claims still encompass a variety of genetically modified biomasses. Mitra suggests that researchers are continuously developing various strategies to realize P4HB synthesis in microbes. Thus, the art suggests that there is no set number of genetic mutations associated with P4HB synthesis.
Applicant argues that the gist of the method lies in introducing a recycled GBL vapor or liquid into the biomass feed and eliminating the need to perform drum drying or spray drying, thereby providing a method that maximizes energy efficiency. Applicant argues that the technical feature of the claimed method resides not in selecting cells containing high levels of P4HB or selecting specific catalysts, but rather in obtaining high-concentration GBL product through process-based features. See the paragraph spanning pages 10-11 of the remarks. Applicant argues that because the gist of the claimed method resides in the process features rather than in the selection of cells or catalysts, a person skilled in the art can practice the invention based on the features recited in claim 1 without undue experimentation. See the second paragraph on page 11 of the remarks.
This argument is not persuasive because Applicant has not pointed to a claimed process-based feature that allows any genetically engineered P4HB containing cell to be used for GBL production commensurate in scope with the instant claims. Applicant asserts that the claimed method eliminates the need to perform drum drying or spray drying. However, the specification states that “[d]rying is necessary because the biomass containing P4HB needs to be heated to above 150˚C for converting P4HB to GBL”. See [0011]. Claim 1 does not limit the temperature to which the biomass suspension and conversion catalyst are heated to in step (c). Therefore, it is unclear how the catalyst selection wouldn’t affect the gist of the claimed method. Furthermore, claim 1 is drawn to a method of producing GBL from a starting biomass containing water and P4HB-containing cells. Therefore, it is unclear how the cell selection wouldn’t affect the gist of the claimed method either. Especially in view of the specification, which teaches a genetically modified E. coli strain specifically designed for high yield production from P4HB from glucose syrup as a carbon feed source. See [0092].
Claim Interpretation
Claim 1 requires four method steps. First, in step (a), a starting biomass is introduced to any apparatus that can serve as an evaporator, wherein the starting biomass contains water and genetically engineered E. coli cells designed to yield P4HB (i.e. a non-naturally occurring amount of P4HB) from glucose syrup as a carbon feed source. Second, in step (b), recycled liquid or vapor GBL is introduced to the evaporator in a weight equivalent to or less than a weight of water removed to obtain a biomass suspension or solution that contains 5 wt% water content or less and comprises P4HB dissolved or suspended in the GBL. The weight of liquid or vapor GBL introduced to the evaporator is not limited because the weight of the water removed is not limited. Therefore, any recycling of liquid or vapor GBL is considered to be a replacement for the water weight. The P4HB is considered to be dissolved or suspended in GBL if the liquid or vapor GBL is recycled into the evaporator containing P4HB. Third, in step (c), the biomass containing 5% wt or less of water is combined with a catalyst, e.g. calcium hydroxide, and heated to convert the P4HB to GBL. Fourth, in step (d), the GBL is collected. The claimed method does not include spray drying, or it does not include drum drying.
Claim 3 requires step (f) removing solids from the biomass suspension or solution by filtration, precipitation or centrifugation, wherein step (f) occurs before step (c). The claim does not describe where the solids are required to be removed from. Therefore, claim 4 requires a filtration, precipitation or centrifugation step before step (c) for the intended purpose of removing/separating the solids.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7, 10-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over van Walsem (US 2014/011,4082, hereafter “Walsem) in view of Wang (CN 104017597, and translation) with evidence from Jiang (Applied Thermal Engineering, 2019, 155, 123-134).
Regarding claim 1, Walsem teaches, in example 11, producing a biomass containing poly-4-hydroxybutyrate (poly-4HB) using a genetically modified E. coli strain specifically designed for high yield production of poly-4HB from glucose syrup as the sole carbon feed source. After fermentation the broth is washed with DI water by adding an equal volume of water (i.e. a starting biomass containing water and P4HB-containing cells), mixing, centrifuging and decanting the water. Next, the washed broth is mixed with Ca(OH)2 standard hydrated lime (i.e. a catalyst). The mixture is then dried in a rotating drum dryer at 125-130˚C. Moisture levels in the dried biomass is approximately 1-2% by weight (i.e. a biomass containing less than 5wt% water). See [0148]. Pyrolysis (i.e. heating) of the dried broth+P4HB+Ca(OH)2 is carried out and the gases generated are swept out and entered into a series of glass condensers or chilled traps. See [0149]. Walsem discloses that, during pyrolysis GBL is collected in the condensate traps below the cooled condensers. See [0150]. The results show that the combined condensate weight is 181 g and includes 6.1% water, 0.06% fatty acids with the balance of the material being GBL products. See [0151]. In example 11, Walsem teaches drum drying (see [0148]) but not spray drying. Therefore, Walsem meets the instantly claimed limitation that requires the method to not include a drying comprising spray drying.
Walsem does not teach (a) introducing the starting biomass to an evaporator, and (b) introducing liquid or vapor GBL to the evaporator as a solvent in a weight equivalent to or less than a weight of water removed to obtain a biomass suspension or solution that contains 5% or less of water based on the weight of the biomass suspension or solution and comprises P4HB dissolved in or suspended in the GBL; wherein the liquid or vapor GBL introduced in step (b) is a recycle GBL that is a part of the collected GBL in step (d) and recycled back to the evaporator to be mixed as a solvent with the biomass.
Wang teaches a biomass catalytic pyrolysis system and method. See [002] and claim 1. Wang teaches drying biomass raw materials in a rotary drying oven to reduce the moisture content to less than 5 wt%. See [0057].
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Crushed dried biomass raw material 1 is mixed with a feed carrier gas 2 to form a reaction feed 3, which enters from the lower part of the circulating fluidized bed 4. The reaction product 5 leaves the top of the circulating fluidized bed reactor 4 and enters the cyclone separator 6, and the solid phase product 7 leaves the bottom of the cyclone separator 6 and enters the air burner 8. After exiting the cyclone separator 6 intermediate products 10 enter a condenser 11. Liquid product 12 exits the lower portion of the condenser is split into three streams: one stream is pressurized by circulating oil pump 15 as circulating oil 16; one stream is pressurized by fuel oil pump 21 as auxiliary fuel oil and one stream enters subsequent bio-oil 14 collection or separation and refining units for processing. The gaseous product 13 leaving the side of the condenser 11 is composed of non-condensable gases and is recycled as the feed carrier gas 2 and the fluidizing gas 20. See [0059]. The circulating fluidized bed of Wang is understood to be an evaporator in view of evidentiary reference, Jiang (see title and abstract).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to apply the biomass pyrolysis method of Wang to the dried broth+P4HB+Ca(OH)2 of Walsem. Doing so is merely the application of a known pyrolysis technique. In the process, one would arrive at a method in which the dried broth+P4HB+Ca(OH)2 of Walsem is introduced into the circulating fluidized bed 4 (i.e. an evaporator) of Wang as dried biomass raw material, and, consequently, the gaseous GBL product of Walsem would leave the side of the condenser 11 to be recycled as a feed carrier gas 2 or fluidizing gas 20 into a circulating fluidized bed 4, as taught by Wang; and wherein amount of GBL product recycled into the circulating fluidized bed would be less than the weight of water lost because the starting dried biomass has a moisture content of approximately 1-2% by weight at the start. One would be motivated to use the pyrolysis technique of Wang because Walsem suggests partially condensing the GBL vapor product to remove higher boiling compounds like bio-oil; and Wang teaches a condenser 11 that separates a gaseous product 13 from bio-oil. Furthermore, Wang suggests that the process flow is simple, operation is easy and it can be applied to various biomass raw materials (see [0008]). There would be a reasonable expectation of success because Walsem demonstrates performing pyrolysis on a dried biomass with a moisture content that is approximately 1-2% by weight and Wang teaches a pyrolysis system for biomass with a moisture content less than 5 wt%.
Regarding claim 2, Walsem teaches producing a biomass containing P4HB using a genetically modified E. coli strain. After fermentation the broth is washed with DI water by adding an equal volume of water, mixing for 2 minutes and centrifuging and decanting the water. See [0148]. Furthermore, Walsem teaches combining the catalyst and biomass by mixing, flocculation, centrifuging or spray drying or other suitable methods known in the art for promoting interaction of the biomass and catalyst driving an efficient and specific conversion of P4HB to GBL. See [0072]. In example 9, the E. coli strain generates a fermentation broth that has a P4HB titer of approximately 100-120 g/kg of broth. After fermentation 100 g of the fermentation broth, e.g. P4HB biomass, is mixed with an aqueous slurry containing lime Ca(OH)2. See [0134]. Thus, Walsem teaches the active method step of mixing host cells containing P4HB.
Regarding claim 3, Walsem teaches, in example 11, producing a biomass containing P4HB using a genetically modified E. coli strain specifically designed for high yield production of P4HB from glucose syrup as the sole carbon feed source. After fermentation the broth is washed with DI water by adding an equal volume of water (e.g. starting biomass containing water and P4HB-containing cells), mixing for 2 minutes and centrifuging and decanting the water. Next, the washed broth is mixed with lime, Ca(OH)2 standard hydrated lime. The mixture is then dried in a rotating drum dryer at 125-130˚C. Moisture levels in the dried biomass is approximately 1-2% by weight (e.g. biomass suspension or solution that is substantially free of water). See [0148]. Pyrolysis (e.g. heating) of the dried broth+P4HB+Ca(OH)2 is carried out. See [0149]. Thus, Walsem teaches the active method step of centrifuging a washed fermentation broth, before heating, which inherently separates solids, absent evidence to the contrary.
Regarding claim 4, Walsem teaches, in example 11, producing a biomass containing P4HB. After fermentation the broth is washed with DI water by adding an equal volume of water, mixing for 2 minutes and centrifuging and decanting the water. Next, the washed broth is mixed with lime, Ca(OH)2 standard hydrated lime. The mixture is then dried in a rotating drum dryer at 125-130˚C. Moisture levels in the dried biomass is approximately 1-2% by weight (e.g. biomass suspension or solution that is substantially free of water). See [0148]. Thus, Walsem teaches removing, not adding water, via decantation and drying.
Wang mentions water, but Wang only teaches a condenser that is a shell and tube heat exchanger and the cooling medium is circulating water. See claim 2 of Wang. Thus, Wang indicates that the condenser uses external circulating water for cooling. As such, Wang does not teach adding water.
Regarding claim 7, Walsem teaches heating done in a vacuum, at atmospheric pressure or under controlled pressure. See [0077]. Walsem teaches low temperatures for removing water, such as between 25˚C and 150˚C. See [0072].
Walsem does not teach an evaporator (relevant to step (a) of claim 1); and Walsem does not teach heating to a temperature of 60-100˚C under the vacuum.
Wang discloses that the circulating fluidized bed (i.e. an evaporator). See claim 6 of Wang and paragraph [0026].
Walsem and Wang do not teach a temperature from 60-100 ˚C under vacuum.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to apply the heating technique of Walsem to the circulating fluidized bed (e.g. evaporator) of Wang, and to further optimize the temperature within the 25-150˚C range taught by Walsem. One would be motivated to apply the heating technique of Walsem to the circulating fluidized bed of Wang, because Walsem suggests that such heating is appropriate for the thermal degradation of the P4HB biomass. See [0077] of Walsem. There would be a reasonable expectation of success because Wang teaches using the circulating fluidized bed for the pyrolysis of biomass, which is a form of thermal degradation. One would be further motivated to optimize the temperature of the heating because Walsem suggests removing water at low temperatures, such as 25-150˚C. There would be a reasonable expectation of success because the 25-150˚C range of Walsem overlaps with the instantly claimed 60-100˚C range. MPEP 2144.05(II) states that “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, Walsem teaches mixing the washed broth with Ca(OH)2 standard hydrated lime. The mixture is then dried in a rotating drum dryer at 125-130˚C. See [0148]. Walsem teaches some embodiments, in which the heating is done in a vacuum, at atmospheric pressure or under controlled pressure. See [0077].
Walsem and Wang do not teach step (a) carried out at a temperature from 70˚C-90˚C under vacuum.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to optimize the temperature in the circulating fluidized bed (e.g. evaporator) of Wang and to further apply the vacuum heating technique of Walsem. One would be motivated to adjust the temperature because a person of ordinary skill in the art has good reason to pursues the known options within their technical grasp. There would be a reasonable expectation of success because Walsem suggests processing biomass at a temperature 125-130˚C, which may serve as a starting point from which one could optimize. MPEP 2144.05(II)(A) states that “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would be further motivated to use the vacuum heating technique of Walsem because a person of ordinary skill in the art has good reason to pursue the known options within their technical grasp. There would be a reasonable expectation of success because Walsem teaches a finite list of heating options to choose from.
Regarding claim 11, Walsem teaches a process for the production of biobased tetrahydrofuran product comprising combining genetically engineered biomass and a first catalyst, wherein the biomass comprises P4HB and heating the biomass with the first catalyst to convert P4HB to GBL vapor, wherein the heating is for a time period from about 30 seconds to about 5 minutes or from about 5 minutes to about 2 hours. See claims 1 and 16 of Walsem.
Regarding claim 12, Walsem teaches a process for the production of biobased tetrahydrofuran product comprising combining genetically engineered biomass and a first catalyst, wherein the biomass comprises P4HB and heating the biomass with the first catalyst to convert P4HB to GBL vapor, wherein the GBL vapor comprises less than 5% by weight of side products. See claims 1 and 18 of Walsem.
Regarding claim 14, Walsem teaches a process for the production of biobased tetrahydrofuran product comprising combining genetically engineered biomass and a first catalyst, wherein the biomass comprises P4HB and heating the biomass with the first catalyst to convert P4HB to GBL vapor. See claim 1 of Walsem. Walsem teaches a first catalyst that is sodium carbonate or calcium hydroxide or mixtures thereof. See [0026] and example 11 [0148].
Regarding claim 15, Walsem teaches a GBL product yield ((g of GBL product/g of starting P4HB)x100) calculated to be approximately 87%. See example 11 [0151].
Regarding claim 17, Walsem teaches producing high purity, high yield biobased GBL from pyrolysis of fermentation broth+P4HB+catalyst mixture. See [0147]. Walsem teaches GBL product yield calculated to be approximately 87%. See example 11 [0151].
Regarding claim 18, Walsem teaches a process for the production of biobased tetrahydrofuran product comprising combining genetically engineered biomass and a first catalyst, wherein the biomass comprises P4HB and heating the biomass with the first catalyst to convert P4HB to GBL vapor, wherein the GBL vapor comprises less than 5% by weight of side products. See claims 1 and 18 of Walsem.
(Maintained) Claims 5-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over van Walsem (US 2014/011,4082, hereafter “Walsem) in view of Wang (CN 104017597), as applied to claims 1-4, 7, 10-12, and 14-18 above, and further in view of Harris (US 2015/0183708) and Clark (US 2011/0003355 ).
The teachings of Walsem and Wang with respect to instant claim 1 are discussed above.
Regarding claim 5, Walsem teaches, in example 11, producing a biomass containing poly-4-hydroxybutyrate (poly-4HB) using a genetically modified E. coli strain specifically designed for high yield production of poly-4HB from glucose syrup as the sole carbon feed source. After fermentation the broth is washed with DI water by adding an equal volume of water (e.g. starting biomass containing water and P4HB-containing cells), mixing for 2 minutes and centrifuging and decanting the water. Next, the washed broth is mixed with lime, Ca(OH)2 standard hydrated lime. The mixture is then dried in a rotating drum dryer at 125-130˚C. Moisture levels in the dried biomass is approximately 1-2% by weight (e.g. biomass suspension or solution that is substantially free of water). See [0148]. Pyrolysis (e.g. heating) of the dried broth+P4HB+Ca(OH)2 is carried out. See [0149].
Wang teaches a circulating fluidized bed 4, which is understood to be an evaporator. See [0059] and number 4 in the figure above. Wang teaches a gaseous product 13 that is recycled as a feed carrier gas 2 and fluidizing gas 20, such that it is supplied to the circulating fluidized bed 4. See the figure provided above.
Walsem and Wang do not teach multiple serial evaporators that are in fluid communication with each other and the recycle GBL is introduced to one or more of the evaporators.
Harris teaches preparing poly-3-hydroxpropionate (P3HP) biomass from genetically engineered E. coli in a fermenter using glucose as feed supplemented with vitamin B12. After fermentation, the biomass is either washed using centrifugation or is concentrated directly using a triple effect evaporator. The concentrated broth is then dried using either a spray dryer or a double drum dryer. See [0147]. Harris discloses that P3HP is defined to include a copolymer, such as 4 hydroxybutyrate. See [0047].
Walsem, Wang and Harris do not teach multiple serial evaporators that are in fluid communication with each other and the recycle GBL is introduced to one or more of the evaporators.
Clark teaches a process of isolating 1,4-butanediol (1,4-BDO) from a fermentation broth comprising separating a liquid fraction enriched in 1,4-BDO from a solid fraction comprising cells, removing water from said liquid fraction, removing salts from said liquid fraction, and purifying 1,4-BDO. See claim 1 of Clark. The step of separating said liquid fraction comprises centrifugation. See claim 1 of Clark. The water is removed by evaporation with an evaporator system comprising one or more effects. See claim 9 of Clark. Said evaporator system comprises a double or triple-effect evaporator. See claim 10 of Clark. The evaporator system is selected from a list that includes a circulation evaporator, and a fluidized bed evaporator. See claim 13 of Clark. Clark suggests that evaporation configurations such as multiple effects or mechanical vapor recompression allows for reduced energy consumption. See [0100]. In a multiple effect arrangement, Effect I operates under the highest pressure. Vapor from effect I is used to heat Effect II (e.g. fluid communication), which consequently operates at lower pressure. This continues through each additional effect. See [0103].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to replace the circulating fluidized bed 11 of Wang with the triple-effect evaporator of Clark. Doing so is mere substitution. One would be motivated to use a triple-effect evaporator, because Harris suggests concentrating biomass from genetically engineered E. coli via a triple effect evaporator. One would be motivated to use the triple-effect evaporator of Clark because Clark suggests that the configuration may reduce energy consumption. There would be a reasonable expectation of success because Harris suggests that biomass from genetically engineered E. coli can be either be washed using centrifugation or concentrated directly using a triple effect evaporator. In other words, Walsem teaches washing and centrifuging biomass from genetically engineered E. coli, but Harris suggests that the biomass may instead be concentrated by a triple effect evaporator; and Clark teaches a triple-effect evaporator.
Regarding claim 6, Walsem teaches heating a biomass comprises P4HB with a first catalyst to convert P4HB to GBL vapor. See claims 1 and 16.
Wang teaches a circulating fluidized bed 4, which is understood to be an evaporator. See [0059] and number 4 in the figure above. Wang teaches a gaseous product 13 that is recycled as a feed carrier gas 2 and fluidizing gas 20, such that it is supplied to the circulating fluidized bed 4. See the figure provided above.
Walsem and Wang do not teach a first evaporator, a second evaporator and a third evaporator.
Clark discloses that in a multiple effect evaporator arrangement, Effect I operates under the highest pressure. Vapor from effect I is used to heat Effect II (e.g. fluid communication), which consequently operates at lower pressure. This continues through each additional effect. See [0103]. Clark discloses that evaporator trains, the serially connected effects, can receive feed in several different ways. See [0104]. For backward feed arrangements, III, II, I can be used. In such a configuration multiple pumps are used to work against the pressure drop of the system, however, since the feed is gradually heated, they can be more efficient than a forward feed configuration. This arrangement also reduces the viscosity differences through the system and is thus useful for viscous fermentation broths. In some embodiments, mixed feed arrangements can be utilized, with the feed entering in the middle of the system, or effects II, III, and I. See [105].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to replace the circulating fluidized bed 11 of Wang with the triple-effect evaporator of Clark, as discussed above, and to further arrange the effects of the triple-effect evaporator of Clark such that feed is in a backward feed configuration. Doing so is merely pursuing known options. One would be motivated to use a backward feed configuration for viscous fermentation broths. There would be a reasonable expectation of success because Clark provides a finite number of configurations for a triple effect evaporator.
Regarding claim 8, Walsem teaches a dried biomass with a moisture content of approximately 1-2% by weight. See [0148].
Wang teaches drying biomass raw materials in a rotary drying oven to reduce the moisture content to less than 5 wt%. See [0057].
Harris teaches a dried biomass with a moisture level of approximately 1-2%. See [143].
Clark teaches removing a portion of water in any amount including 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 50%, 60%, 70%, 80%, and all values in between. See [0099]. Clark discloses in a multiple effect arrangement, the latent heat of the vapor product off of an effect is used to heat the following effect. See [103].
Walsem, Wang, Harris and Clark do not teach removing 20-50% of water contained in the starting biomass in the first evaporator, removing 20-45% of water contained in the starting biomass in the second evaporator, and removing 5-35% water contained in the starting biomass in the third evaporator.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the portion of water removed in each evaporator of the triple effect evaporator taught by Clark. One would be motivated to optimize the amount of water removed because Clark suggests that the vapor product of the first effect impacts the heating of the following effect. There would be a reasonable expectation of success because Clark teaches removing a portion of water in any amount. MPEP 2144.05(II) “[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
§ 103 rejection of claims 1-4, 7, 10-12, and 14-18 over Walsem and Wang with evidence from Jiang
Applicant argues that Walsem and Wang fail to teach or suggest: a biomass suspension or solution “that contains 5 wt% or less of water based on the weight of the biomass suspension or solution”, and “liquid or vapor GBL introduced in step (b) is a recycle GBL”. See the paragraph spanning pages 12-13 of the remarks.
This argument is not persuasive because Walsem and Wang teach the claimed limitations pointed out by Applicant. Specifically, Walsem teaches a biomass with a moisture content that is approximately 1-2% by weight, which is less than 5 wt% water (see [0148]) and Wang teaches a biomass with a moisture content less than 5wt% (see [0057]). Furthermore, Wang teaches a pyrolysis system in which gaseous products are removed from a circulating fluidized bed (i.e. evaporator) and recycled back in as a feed carrier gas or as fluidizing gas. As discussed in the rationale above, it would’ve been obvious to apply the pyrolysis technique of Wang to the biomass of Walsem.
Applicant argues that Walsem and Wang fail to teach a method that does not include a drying comprising spray drying or drum drying, thereby exhibiting significantly superior energy efficiency and enabling improvements in GBL yield and purity, and employs a partial GBL recycle stream as a means of achieving the objectives. See the paragraphs spanning pages 12-13 and 13-14 of the remarks. Walsem and Wang teach removing moisture from biomass through drum drying. See the first paragraph on page 14 of the remarks.
This argument is not persuasive because it is not commensurate in scope with the claims. Claim 1 is open-ended due to the term “comprising” recited in line 3. As such, the claims encompass additional method steps not recited within the claim. Claim 1 recites the method does not include “a” [singular] drying comprising “spray drying or drum drying”. See line 16. Therefore, the claim requires the method to exclude either spray drying or drum drying. The method in example 11 of Walsem includes drum drying, but excludes spray drying. See [0148] for the drum drying step in example 11 of Walsem. The only reference to spray drying taught by Walsem is in paragraph [0072], which states that “[t]he catalyst (in solid or solution form) and biomass are combined for example by mixing, flocculation, centrifuging or spray drying”. Thus, Walsem does not suggest that spray drying is necessary. As such, the argument is not persuasive because the claims encompass method embodiments that include drum drying.
Applicant argues that Walsem merely discloses that a part of the gas generated by the reaction is collected through a condenser and contains no disclosure or suggestion of implementing this as a recycle stream. Wang, on the other hand, discloses that already-dried biomass is mixed with a carrier gas and introduced into a circulating fluidized bed reactor. Therefore, the claimed method clearly differs from that of Walsem and Wang in that the claimed method controls the moisture content of 5 wt% or less in the evaporator while mixing with a recycled GBL stream.
This argument is not persuasive because one cannot show non-obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Applicant is addressing the teachings of Walsem and Wang separately. However, the rejection is based on the combination of teachings. Walsem teaches collecting gas through a condenser and Wang teaches a condenser in which gas is recycled back into a circulating fluidized bed (evaporator). Thus, the claimed limitation is met by the combination of Walsem and Wang. Furthermore, Applicant asserts that Walsem and Wang do not teach a method that controls the moisture content of 5 wt% or less in the evaporator while mixing with a recycled GBL stream. However, this argument is not commensurate in scope with the claims, because the claims do not require the evaporator to control the moisture content of the biomass.
§ 103 rejection of claims 5-6 and 8 over Walsem, Wang, Harris and Clark
Applicant argues that Harris and Clark do not make up for the deficiencies of Walsem and Wang. In view of the above, the present claims are not obvious and are patentable over the cited references. See paragraphs 2-3 on page 14 of the remarks.
This argument is not persuasive for reasons discussed above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10-12, 14-15 and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-28 of U.S. Patent No. 9,084,467 (as cited in the IDS filed 03/28/2023; hereafter Walsem ‘467) in view of Walsem (US 2014/011,4082, hereafter “Walsem), Wang (CN 104017597), Harris (US 2015/0183708) and Clark (US 2011/0003355 ).
Claim 1 of Walsem ‘467 recites a process for production of a biobased gamma-butyrolactone product, comprising
a) combining a genetically engineered biomass comprising poly-4-hydroxybutyrate and a catalyst; and
b) heating the biomass with the catalyst to convert the poly 4-hydroxybutyrate to a gamma-butyrolactone product, wherein the catalyst is sodium carbonate or calcium hydroxide.
Claim 4 of Walsem ‘467 recites the process of claim 1, wherein the process further includes an initial step of culturing a recombinant host with a renewable feedstock to produce a poly-4-hydroxybutyrate biomass.
Claim 12 of Walsem ‘467 recites the process of claim 1, wherein heating reduces the water content of the biomass to about 5 wt %, or less.
Claim 27 of Walsem ‘467 recites the product of claim 26, wherein the gamma-butyrolactone product comprises less than 5% by weight of side products.
Claim 30 of Walsem ‘467 recites the process of claim 1, wherein product is about 85% by weight or greater based on one gram of a gamma-butyrolactone in the product per gram of poly-4-hydroxybutyrate.
The patent claims of Walsem ‘467 lack (a) introducing the starting biomass to an evaporator, (b) introducing liquid or vapor GBL to the evaporator as a solvent in a weight equivalent to or less than a weight of water removed to obtain a biomass suspension or solution that contains 5 wt% or less water and comprises P4HB dissolved or suspended in the GBL, and (d) collecting the GBL, wherein the liquid or vapor GBL introduced in step (b) is a recycle GBL that is a part of the collected GBL obtained in step (d) and recycled back to the evaporator to be mixed as a solvent with the biomass, and wherein the method does not include a drying comprising drum drying or spray drying (relevant to instant claim 1). The patent claims of Walsem ‘467 lack step (e) mixing, stirring, vortex, or agitation to promote extraction of P4HB from host cells into GBL (relevant to instant claim 2). The patent claims of Walsem ‘467 lack step (f) removing solids from the biomass suspension or solution that is substantially free of water, by filtration, precipitation, or centrifugation (relevant to instant claim 3). The patent claims of Walsem ‘467 lack no water is added in steps (a), (b), and (c) (relevant to instant claim 4). The patent claims of Walsem ‘467 lack an evaporator that comprises multiple serial evaporators that are in fluid communication with each other and the recycle GBL is introduced to one or more of the evaporators (relevant to instant claim 5). The patent claims of Walsem ‘467 lack an evaporator contains a first evaporator, a second evaporator, and a third evaporator, which are in fluid communication with each other in serial in this order, and the recycle GBL is introduced into the second evaporator and/or the third evaporator (relevant to instant claim 6). The patent claims of Walsem ‘467 lack a temperature of from 60° C - 100° C under vacuum and at atmospheric pressure (relevant to instant claim 7). The patent claims of Walsem ‘467 lack 20-50% of water contained in the starting biomass is removed in the first evaporator, 20-45% of water contained in the starting biomass is removed in the second evaporator, and 5-35% water contained in the starting biomass is removed in the third evaporator; and wherein the recycled GBL is introduced to replace the water removed from the first and the second evaporator (relevant to instant claim 8). The patent claims of Walsem ‘467 lack a step (a) that is carried out at a temperature from 70° C - 90° C under vacuum (relevant to instant claim 10). The patent claims of Walsem ‘467 lack a biobased gamma-butyrolactone product produced by the method of instant claim 1 (relevant to instant claim 17), and consequently lack a gamma-butyrolactone product comprises less than 5% by weight of side products (relevant to instant claim 18).
However, Walsem teaches performing pyrolysis on a dried broth from P4HB producing E. coli cells+Ca(OH)2 to produce GBL from the thermal degradation. See [0148]-[0151]. The GBL is collected in condensate traps. See [0150]. Wang teaches a pyrolysis system and method. See [0002]. Crushed dried biomass is mixed with a feed carrier gas, which enters a circulating fluidized bed. Reaction products leave the top of the circulating fluidized bed reactor to enter a cyclone separator. Intermediate products enter a condenser. The gaseous product leaving the condenser is recycled as the feed carrier into the circulating fluidized bed. See [0059] (relevant to instant claims 1, 17 and 18). Walsem teaches mixing the catalyst and biomass. See [0072] (relevant to instant claim 2). Walsem teaches centrifuging washed fermentation broth before heating. See [0148-0149] (relevant to instant 3). Walsem teaches removing water. See [0148]. Wang do not teach an active method step of adding water (relevant to instant claim 4). Harris teaches washing and centrifuging biomass from genetically engineered E. coli or concentrating it in a triple effect evaporator. See [0047]. Clark teaches a triple effect evaporator. See claim 10 of Clark. Clark discloses that the vapor of effect 1 is used to heat effect II, which continues through each additional effect (e.g. fluid communication). See [0103] (relevant to instant claim 5). Clark teaches a backward feed arrangement where III, II, I can be used. See [0105] (relevant to instant claim 6). Wang teaches heating in a vacuum under at atmospheric pressure or under controlled pressure. See [0077] (relevant to instant claim 7). Clark teaches removing a portion of water in any amount including. See [0099] (relevant to instant claim 8). Walsem teaches drying a mixture of biomass and the catalyst at 125-130˚C. See [0077] (relevant to instant claim 10).
It would have been obvious to a person of ordinary skill in the art to apply the pyrolysis technique of Wang to the biomass of Walsem ‘467, to replace the circulating fluidized bed of Wang with the triple effect evaporator of Clark in any configuration, and to further optimize the temperature and pressure of the evaporator in order to produce a biobased GBL product.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Double Patenting rejection over Walsem ‘467, Walsem, Wang, Harris and Clark
Applicant argues that Walsem ‘467 does not include limitations corresponding to steps (a), (b) and (d) of claim 1, nor does it exclude a drying step. Applicant argues that Walsem, Wang, Jiang, Harris and Clark do not disclose any configuration that excludes a drying step such as drum drying or spray drying. Also, Walsem ‘467 differs in that it does not include the specific process feature of introducing recycled GBL. The cited referenced do not disclose that specific process feature either. See the second and third paragraphs on page 15 of the remarks.
This argument is not persuasive, because claim 1 does not exclude all forms of drying. Rather, claim 1 excludes drum drying or excludes spray drying. Furthermore, the instantly required GBL recycle step is taught by the combination of Walsem and Wang. Thus, every claimed element is taught by the combination of Walsem ‘467, Walsem, Wang, Harris and Clark.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657